Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT03364257
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 5 years and weight \> 16 Kg
2. Patients having signed the written study informed consent form (ICF) prior to any study-mandated procedure. For children/adolescents: ICF obtained from both children's parents/ legal representative prior to any study-mandated procedure, and in addition for adolescents (13-17 years): assent form to be signed
3. Patient presenting severe neutropenia (absolute neutrophil count \< 0.5 Giga/L) anticipated to be long lasting (\> 10 days) following intensive chemotherapy for acute myeloid or lymphoid leukaemia (AML or ALL) or myelodysplastic syndrome or in the context of hematopoietic stem cells transplantation
4. Febrile episode (oral temperature \> 38.3°C once, or 2 measures \> 38.0°C taken 2h apart).
Exclusion Criteria:
1. Known HIV infection or AIDS diagnosis
2. Already microbiologically confirmed infection
3. Patient status preventing the study test to be performed
4. Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT03364257
Study Brief:
Protocol Section:
NCT03364257